Shares of Mirati were down 7.4% on Jul 21, after the European Medicine Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) did not recommend approving the company’s conditional marketing authorisation application (“MAA”) for Krazati (adagrasib) in KRASG12C-mutated advanced non-small cell lung cancer (“NSCLC”).

The CHMP noted that the Krazati MAA does not fulfill certain requirements for a conditional approval. Mirati was unable to show that Krazati fulfils an unmet need. Per the CHMP, the data supporting the MAA was not comprehensive and there were uncertainties on how well the drug worked.

However, Mirati disagrees with the CMP’s recommendation and believes that Krazati possesses a differentiated clinical profile compared to Amgen’s (AMGN Quick QuoteAMGN - Free Report) Lumakras/Lumykras, an approved KRASG12C inhibitor. Management intends to request for a formal re-examination of the opinion.

The above CHMP opinion will not impact any of Mirati’s clinical studies. The company is currently enrolling participants in the confirmatory phase III KRYSTAL-12 study evaluating Krazati monotherapy against docetaxel in second-line NSCLC. Data from this confirmatory study, which is expected to support full approval for Krazati, is expected in first-half 2024.

If the re-examination is not successful, it could delay Krazati’s EU launch by more than a year since data from the KRYSTAL-12 study will not be available till next year.

The MAA is supported by data from the phase II registration-enabling cohort of the KRYSTAL-1 study evaluating the drug in patients with KRASG12C mutated advanced NSCLC, previously treated with a platinum-based regimen and an immune checkpoint inhibitor. The study achieved an objective response rate of 43% at the median duration of response being 8.5 months.

Krazati was granted accelerated approval by the FDA last December to Krazati for previously-treated KRASG12C-mutated locally advanced or metastatic NSCLC. This approval was also based on data from the KRYSTAL-1 study.

In the year so far, Mirati’s shares have declined 30.9% compared with the industry’s 10.0% fall.

Image Source: Zacks Investment Research

Tumors characterized by KRAS mutations are extremely difficult to directly inhibit and are commonly associated with poor prognosis and resistance to therapy. KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinomas patients, 3-4% of colorectal cancer (CRC) patients and smaller percentages of several other difficult-to-treat cancers. Krazati will be launched as a tablet formulation for advanced NSCLC patients who have a KRAS mutation and progressed beyond a first-line treatment.

Mirati is evaluating adagrasib — as monotherapy and combinations — in multiple cohorts of the KRYSTAL-1 study across multiple solid tumors that harbor KRASG12C mutations. These include the combination of adagrasib with Merck’s Keytruda in NSCLC, the combination with Boehringer Ingelheim’s Gilotrif (afatinib) in advanced NSCLC and Eli Lilly’s Erbitux (cetuximab) in advanced CRC. In several other studies, adagrasib is being evaluated as a monotherapy and in combination with other anti-cancer therapies for advanced KRASG12C- mutated solid tumors, including NSCLC, colorectal cancer and pancreatic cancer.

In the United States, Krazati competes with Amgen’s Lumakras/Lumykras, which was approved for second-line NSCLC in the United States in 2021 and Europe in January 2022. The Amgen drug has been launched in more than 50 countries. Amgen’s Lumakras/Lumykras is off to an excellent start, while its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly.

Mirati Therapeutics, Inc. Price

 

Mirati Therapeutics, Inc. price | Mirati Therapeutics, Inc. Quote

Zacks Rank & Stocks to Consider

Mirati currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall the overall healthcare sector are Omega Therapeutics (OMGA Quick QuoteOMGA - Free Report) and Werewolf Therapeutics (HOWL Quick QuoteHOWL - Free Report) . While Werewolf Therapeutics sports a Zacks Rank #1 (Strong Buy) at present, Omega Therapeutics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Werewolf Therapeutics’ 2023 loss per share have narrowed from $1.42 to $1.29. During the same period, the loss estimates per share for 2024 have improved from $1.81 to $1.37. Year to date, shares of HOWL have surged 82.9%.

Earnings of Werewolf Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 5.29%, on average. In the last reported quarter, HOWL’s earnings beat estimates by 30.61%.

In the past 60 days, estimates for Omega Therapeutics’ 2023 loss per share have narrowed from $2.18 to $2.05. During the same period, the loss estimates per share for 2024 have improved from $2.22 to $2.01. In the year so far, shares of OMGA have lost 6.1%.

Earnings of Omega Therapeutics beat estimates in two of the last four quarters, missed the mark on one occasion while meeting the mark on another. On average, the company witnessed an earnings surprise of 8.24%. In the last reported quarter, OMGA’s earnings beat estimates by 21.88%.